Deadly Medicines and Organised Crime
Page 46
In contrast, our politicians understand so little that they usually only make the situation worse when they act. Keeping people healthy is not a priority in America’s profit-driven system, which thrives when people are ill.12 The propaganda has made nearly half of all Americans believe that the United States has the best healthcare in the world, albeit with a clear political divide (68% of the Republicans and 32% of Democrats).16 The beliefs that what is good for big pharma is also good for the people and that market forces will solve all problems are contradicted by the facts. The Unites States has the most ineffective healthcare system in the developed world.17,18 The three countries with the lowest healthy life expectancies, Hungary, Poland and Slovakia, are former communist countries (see Figure 21.1). The Unites States has a relatively low healthy life expectancy despite the fact that this country uses far more resources than any other country. A 2008 report from the Commonwealth Fund found that the Unites States ranked last among 19 industrialised countries across a range of measures of healthcare.19 The report estimated that if the United States attained the same performance indicators achieved in other industrialised countries, at least 100 000 lives and at least $100 billion could be saved every year, and it tied much of the problem to a weak base of primary care doctors. A study that compared 3075 US counties found that every 20% increase in primary care physicians was associated with a 6% reduction in total mortality.20 The relative position of the United States on health indicators among OECD countries also worsened in the period where the proportion of specialists increased.
Figure 21.1 Healthy life expectancy in relation to the amount spent on healthcare in developed countries (in percent of the gross national product)
Data were available for Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Japan, Luxembourg, Netherlands, New Zealand, Norway, Poland, Portugal, Slovakia, Spain, Sweden, Switzerland, United Kingdom and the United States.
The waste in the United States is gigantic. In relation to the size of the population, the Unites States spent 2.7 times more on drugs than European countries in 2000, and yet – or perhaps because of this – the outcome is much worse.21
The data in Figure 21.1 are about 10 years old; currently, the Unites States is even worse off than in the figure, as it spends about 18% of its GDP on healthcare,22 about double as much as in other industrialised countries. The health disadvantage of Americans is not only because of extreme income inequalities and widespread poverty. It is also seen among those with a health insurance, a college education, higher incomes and healthy behaviours. Even for deaths considered amenable to health care, Americans fare poorly. The decline in amenable mortality in 19 industrialised countries averaged 16% over a 5-year period, whereas it was only 4% for the United States.23 What is also striking in Figure 21.1 is that there isn’t any relation between the amount of money spent on healthcare and life expectancy.
The United Kingdom has come to resemble the United States more and more, as it has moved towards greater privatisation of healthcare. Its healthy life expectancy is lower than in most other European countries, and its prevalence of chronic disease and disability lies between that in the Unites States and the rest of Europe.24
Such sobering facts tell us so clearly that capitalism and privatisation impact negatively on public health and they explain why the vast majority of European doctors are left wing when it comes to healthcare. We feel nervous about profit taking any role in the caring professions, even those of us who might be right wing for other political issues. We love our public health service, which US politicians scornfully call socialised medicine.
How much medicine do we really need and at what cost?
We waste huge amounts of money on drugs where the patients would have been better off without them. Hypertension is a good example that one cannot just look at the benefits of prevention. When investigators asked how it went for 75 patients with controlled hypertension, their doctors said they had all improved, whereas only 36 of the patients felt they had improved and only one of the relatives said so. The questionnaire completed by the relatives rated 22 of the patients to have suffered severe adverse changes: undue preoccupation with sickness; decline in energy, general activity and sexual activity; and irritability. The reason why all the doctors were satisfied was that none of their patients had made complaints!25
Screening for hypertension doesn’t seem to have any beneficial effects,26 whereas it may have untoward consequences. A 1984 study of Canadian steel workers showed that those labelled as patients with hypertension through screening had increased absenteeism from work and suffered a decline in marital adjustment, and in the fifth year after screening they earned $1093 less than colleagues who 5 years earlier had comparable wages.27 This effect on income was seen even in those who didn’t take their antihypertensive drug.
We should also consider that the arteries become more rigid with advancing age and that lowering blood pressure in the elderly may lead to vertigo and falls. In a study where the elderly were their own control, start of antihypertensive medication increased the risk of hip fracture by 43%.28 A quarter of those who suffer a hip fracture die within 1 year,29 e.g. from pneumonia or thrombosis caused by immobilisation. A professor emeritus of cardiology said: Let’s not turn elderly people into patients but let’s allow them to enjoy being healthy (i.e. free from drugs).30
It can be life-saving to treat seriously elevated blood pressure and the adverse effects of the drugs we use are therefore a minor issue. However, harms of drugs are usually the same for patients who are seriously ill as for those who are not. The benefit–harm balance may therefore change from beneficial to harmful, as we move towards treating people who are healthy but happen to have an elevated risk factor. It’s very costly to treat all these healthy people and give them an insurance that their risk of some unhappy event will be a little less if they take the drug for the rest of their lives. As no one subsidises the insurance on our house or car, we could discuss whether it’s reasonable to use taxpayer money on drug insurance. Economists use a concept called willingness to pay. If it costs €3000 to treat one person in 5 years prophylactically and this prevents one untoward event for every 30 people treated, what would a person then decide if he was to pay himself for the drug insurance? Would all 30 happily pay the €3000 for a chance of one in 30 to win in the lottery while enduring the side effects of the drug for 5 years? I am pretty sure some would prefer to use the money for a vacation or something else, at least I would.
If we used medicines rationally, we would have much healthier populations, at a fraction of the expenditure we currently have on drugs. In 2012, the top 50 companies sold $610 billion in human prescription pharmaceuticals.31 I have little doubt that we could easily save 95% of this, which are annual savings of $580 billion, as many of our highly used drugs are 20 times more expensive than equally good alternatives, and as we are so much overtreated. Imagine what we could do for $580 billion. Only 17 countries in the world have a GDP greater than this.
I don’t think I exaggerate. Others have estimated that more than $200 billion may be wasted on unnecessary treatment every year in the United States,32 and although this waste includes treatments other than drugs and poor administration, it’s of the same order of magnitude as my estimate, and yet it refers to only one country.
For-profit is the wrong model
Although the drug industry already suffers from corporate obesity, it pushes its drugs to medicate us even more. In 2002, a report from the European Federation of Pharmaceutical Companies identified 20 diseases and conditions for which they thought potentially achievable benefits were not achieved.33 The report warned against undertreatment over 98 pages, but none of its 184 citations were to systematic reviews, although there were many for each of the conditions discussed that could have dampened the hype. For each disease, positive studies were quoted and negative studies were ignored. Not a single study of overtreatment w
as quoted.
Providers of goods and systems also get their share of the cake. Healthcare and pharmaceutical executives were four of the top 10 best-paid executives in the United States in 2010. The top earner, John Hammergren, was chief executive of the drug distributor McKesson Corp., with total remuneration of $145 million.34 If the poor guy were to be fired, he would receive $469 million in severance pay, or 10 000 times as much as the median US household income. What can one say about such obscenity? Well, at least we can see what’s wrong with the United States’ culture of unlimited greed and cheating.35 The average ratio between CEO compensation and employee is about 13 : 1 in Germany and 11 : 1 in Japan. It was also 11 : 1 in the United States in 1970 but is now a staggering 531 : 1. The US bonus system creates a minimal incentive for innovation and a huge incentive for fraud. In large drug firms, the value of unexercised stock options held by the top executives is often larger than $50 million, which creates an incentive to increase the stock prices and then ‘take the money and run’.35
Unfortunately, the Americans seem unwilling to solve their most fundamental problems. This hit the rest of the world with the global financial crisis in 2008 after all brakes on high-risk investments had been removed by foolish politicians guided by equally foolish economists who believe the market will solve all problems and regulate itself. I’m sure we’ll soon run into a worse global recession than in 2008, again caused by the United States. This is a bit odd, since so many Americans are devout Christians. The Bible warns against unlimited greed in so many places that it cannot be overlooked.
Here is an example of the consequences of the perverse incentives we have.36 Aventis developed a drug against cancer, eflornithine, but it didn’t work for cancer, whereas it was highly effective for sleeping sickness. Since patients with sleeping sickness are generally poor, Aventis discontinued making the drug. Later, it turned out that eflornithine was an effective depilatory. The drug went back into production and was now made available to Africans with sleeping sickness at little or no cost, the only reason being that many women in the Western world want to remove facial hair.
The control of medical practice by market economics does not serve the needs of the patients very well and is not compatible with an ethically based profession.37 Business imperatives to make profits do not produce the social benefits claimed by market advocates. Research in the United States has consistently found higher costs, lower quality of care, and higher rates of medical complications and death in for-profit facilities than in public facilities; even billing fraud is far more common in for-profit hospitals than in not-for-profit hospitals.37 Our universities have also jumped on the bandwagon with their university–industry partnerships and obsession with patents. This is detrimental for public-interest science, e.g. studies of occupational hazards and many other types of non-drug prevention of disease have no commercial interest.38
It is inherently immoral that drugs can be patented. We can avoid buying patented merchandise if we think it’s too expensive and we’ll suffer no harm. In contrast, we may die if we cannot afford to buy a patented life-saving drug. The right way to go with drugs is to abandon the current system and replace it by non-profit enterprises that invent, develop and bring new drugs to the market. Several capitalist countries have established state-owned drug companies,39,40 and it was suggested in the UK in 1976 that the government should take over sections of the drug industry.41 This didn’t materialise, but in 2007, the Medical Research Council announced that it planned to do this to speed advances against rare diseases.42
As long as we continue to endure the for-profit model, we could introduce an award system, where drug companies, instead of patent monopoly, would receive a financial award when they have obtained marketing authorisation, the size of which could be related to the degree to which the invention represented a breakthrough. After that, the drugs could be licensed to multiple firms to manufacture and sell at generic prices, which would ensure that also many poor people and countries could afford to use the drugs. The WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property (GSPoA) of May 2008, and the EU Council Conclusions on Global Health in May 2010 both called for needs-driven innovation and for further exploration of innovation models that de-link the cost of research and development from the price of medicines to encourage both needs-driven research and more affordable access to essential medical technologies.43 Such de-linkage would address three weaknesses of the current model of medical innovation: unaffordability, unavailability and unsuitability. It would also dramatically reduce incentives for development of me-too products and the marketing and promotion of medicines that are used irrationally, or that are no better than the alternatives.
Clinical trials
We cannot trust industry trials at all and the reason is simple. We don’t trust a person who has lied to us repeatedly, even though that person might tell the truth sometimes. The industry has broken our trust and it has an enormous conflict of interest. Further, drug companies choose investigators that have long-standing relations with the drug industry and don’t ask uncomfortable questions. To allow industry to do trials on their own drug is like allowing me to be my own judge in a court case. Imagine if I were accused of a crime and turned up in court with boxes containing 250 000 pages of evidence for my innocence that I had produced myself (which is about the volume of clinical documentation for a new drug), and that I told the judge this was the only evidence there was, on which he or she needed to make a verdict. I would be thrown out of court.
It’s very strange that we have accepted a system where the industry is both judge and defendant, as one of the most firm rules in laws of public administration is that no one can ever be allowed to be in a position where they shall evaluate themselves. The fact that drug agencies will look at the submitted material cannot compensate for this transgression, as the evidence has often been deliberately distorted in ways that escape detection. The industry should no longer be allowed to carry out clinical trials, but they could provide funds for academic-led trials. That would be vastly cheaper for industry. The European Society of Cardiology has estimated that university centres can perform drug trials for about one-tenth to one-twentieth the cost of industry trials where there are numerous for-profit middlemen who tack a hefty surcharge.44 Similarly, the National Cancer Institute has estimated that it can do trials for little more than the usual drug cost.40 The last trial I conducted was a multicentre trial of 112 patients with rheumatoid arthritis that were treated with disease-modifying agents or placebo for 6 months,45 and the budget for the trial was less than my monthly salary. We bought the drugs and got the placebos free from the companies. This shows that trials can be done at almost no cost, if doctors want to do them.
The premises for our current system are wrong. Capitalism operates on the principle that private risk yields either private loss or private wealth. But the idea that public risk (patients participating in trials) is turned into private wealth is a perversion of the capitalist ethic and an exploitation of patients.38 We need a major culture change where we see clinical trials as a public enterprise, done for the public good, and performed by independent academic institutions.1,46 Academics can also be biased – or bribed by industry – but such problems can be solved by ensuring effective blinding during data analysis and writing of manuscripts. This was how I did randomised trials.47 I analysed the data under code and produced two different manuscripts. The code wasn’t broken before my co-authors had approved both manuscripts.
While we await a major system change that may never come, we may do our own independent trials of new drugs before we decide whether or not to use them or reimburse them. In the Netherlands, legislation in 1979 enabled the minister to restrict certain technologies to certain hospitals while they were being evaluated by systematic reviews of the literature.48 A fund was created in 1986 of about €16 million a year with the effect that new unevaluated technologies, including drugs, were reimbursed only when
offered ‘as part of a properly designed research study to assess their effects’, i.e. a randomised trial.
Funds for independent trials could be provided by taxes. The drug industry makes huge profits based on publicly funded research and reimbursement of drugs, and it would therefore be reasonable if the industry was taxed to an extent that allows academics to run the trials we need where we compare a new drug against the best available treatment before we decide anything. If we taxed prescriptions with as little as 2%, it would quickly create a large fund for such research. The Italian drug agency requires drug companies to contribute 5% of their promotional expenses apart from salaries, which has created a large fund used partly for independent clinical research.49,50 There are similar initiatives in Spain.50 Funds may also be provided from government or hospital budgets, as independent trials could easily become a source of income rather than an expense. As long as we are running a trial where only half of the patients will get the new expensive drug, we will save half of the drug costs, and when we are done, we will more often than not discover that the new drug has nothing to offer.
The requirement of independent trials before we make decisions would have a tremendous impact not only on the public purse but also on public health. It would no longer be profitable to develop endless numbers of me-too and me-again drugs and the industry would be forced to do innovative research instead of spending its money on marketing. Revival of the Norwegian ‘medical need’ clause would also reduce the amount of me-too drugs. Norway had only seven NSAIDs on the market compared with 22 in the Netherlands, but its medical need clause was eliminated in 1996 when it harmonised its drug approval process with that in the EU.51 As there isn’t much price competition anyway, it wouldn’t matter much for our drug expenses whether there were seven or 22 different drugs of the same type, but it could mean a lot for innovation.